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The purpose of this IMDRF guidance is to provide harmonized recommendations for verification and validation aspects of a patient-matched medical device and a medical device production system (MDPS). The adoption of consistent, harmonized requirements for such medical devices and systems will underpin a harmonized regulatory approach for controls and offer significant benefits to the manufacturer, user, patient, Regulatory Authorities (RAs) and Conformity Assessment Bodies (CABs).
Eliminating differences between jurisdictions supports global convergence, reduces the cost of gaining regulatory compliance, and allows patients and authorized healthcare professionals timely access to new treatments and technologies.

The IMDRF has published IMDRF/PMD WG/N49 Definitions for Personalized Medical Devices, establishing harmonized definitions for various categories of personalized medical devices (PMDs), including custom-made, patient-matched, and adaptable medical devices. This document introduces the concept of a specified design envelope, a characteristic feature in the definition of patient-matched medical device

Another IMDRF document IMDRF/PMD WG/N58 Personalized Medical Devices – Regulatory Pathways, provides recommendations for regulatory pathways for different categories of  PMDs. This document further provides considerations for near or at point-of-care (defined as POC throughout this document) manufacturing and different models of regulatory oversight (manufacturing under special arrangements, MDPSs, fully regulated manufacturing) that may be implemented to ensure the quality, safety and performance of the medical devices produced.


The present guidance is a continuation of these two documents (N49 and N58) and is intended for use by industry, RAs, CABs, and others. The first half of this guidance provides technical considerations for verification and validation aspects of specified design envelope for patient-matched medical devices.
The second half of the guidance covers technical considerations for verification and validation aspects of an MDPS (which is a medical device in its own right).